Endoscopy refers to looking inside a human body for medical reasons using an instrument called an endoscope. Endoscopy is a minimally invasive diagnostic medical procedure used to evaluate interior surfaces of an organ or other tissue by inserting a small tube into the body, often, but not necessarily, through a natural body opening of a patient or through a relatively small incision. Using the endoscope, a surgeon may view surface conditions of the organs or other tissue, including abnormal or diseased tissue such as lesions and other various surface conditions. The endoscope may have a rigid or a flexible tube and, in addition to providing an image for visual inspection and photography, the endoscope may be adapted and configured for taking biopsies, retrieving foreign objects, and introducing medical instruments to a tissue treatment region, referred to generally herein as a surgical site.
Laparoscopic surgery is a minimally invasive surgical technique in which operations are performed through small incisions (usually 0.5 cm-1.5 cm) or keyholes, as compared to the larger incisions required in traditional open-type surgical procedures. Laparoscopic surgery includes operations within the abdominal or pelvic cavities, whereas keyhole surgery performed on the thoracic or chest cavity is called thoracoscopic surgery. Laparoscopic and thoracoscopic surgery belong to the broader field of endoscopy.
A key element in laparoscopic surgery is the use of a laparoscope: a telescopic rod lens system that is usually connected to a video camera (single-chip or three-chip). Also attached is a fiber-optic cable system connected to a “cold” light source (halogen or xenon) to illuminate the operative field and configured to be inserted through a 5 mm or 10 mm cannula to view the surgical site. The abdomen is usually insufflated with carbon dioxide gas to create a working and viewing space for a surgeon. Stated another way, the abdomen is essentially blown up like a balloon (i.e., insufflated) thereby elevating the abdominal wall above the internal organs like a dome. Carbon dioxide gas can be used for the insufflation because it is common to the patient's body and can be removed by the respiratory system if it is absorbed through tissue.
Minimally invasive therapeutic procedures used to treat diseased tissue by introducing medical instruments to the surgical site through a natural opening of a patient are known as Natural Orifice Translumenal Endoscopic Surgery (NOTES™). In general, there are a variety of systems for inserting an endoscope through a natural opening in the human body, dissecting a lumen, and then, treating the inside of the abdominal cavity. For example, in U.S. Pat. No. 5,297,536 to Wilk, issued on Mar. 29, 1994, which is hereby incorporated by reference in its entirety, a sample treatment system is disclosed. This system is comprised of a dissecting device for perforating a lumen wall, an endoscope insert member for inserting an endoscope, a tube, an endoscope, and a pneumoperitoneum device for deflating the abdominal cavity, and a closing device.
When transluminal endoscopic surgery is carried out using the above-referenced system or any other suitable system, an overtube can first be inserted through a natural opening in the patient's body (e.g., mouth, anus, or vagina). A distal end of the overtube may be attached to an organ wall or other tissue by vacuum pressure, thus being temporarily fixed thereon such that the organ wall or other tissue can be punctured. An incising instrument, such as a needle, for example, may be passed through the overtube from a proximal end of the overtube to a distal end of the overtube, and/or through a working channel of the endoscope, and used to puncture and create an opening through the organ wall or other tissue. An inflatable member, such as a medical balloon, for example, may be positioned in the opening and then inflated to enlarge the opening. Once the opening has been enlarged by the inflatable member, the inflatable member can be at least partially deflated and removed from the body and/or retracted into the overtube and the overtube may then be inserted into and partially through the opening to serve as a working channel for the endoscope and/or other surgical instruments or devices to the surgical site. After surgery of the inside of the organ or other tissue is complete, the overtube may be removed from the enlarged opening so that the opening can be closed by an O-ring or other suitable closure device and then the endoscope and the overtube may be withdrawn from the body.
In various techniques, difficulties may arise when inserting the inflatable member through the working channel of the endoscope, through the overtube, through the organ wall, and/or through other tissue. In various circumstances, the inflatable member could be breached if it catches or snags a portion of the working channel, such as an end of the working channel, for example, a portion of the overtube, a portion of the organ wall, and/or other tissue. Additionally, the inflatable member can be prematurely inflated in the overtube owing to subatmospheric pressure conditions within the overtube and surrounding the outside walls of the inflatable member. Accordingly, in the field of endoscopy, there remains a need for improved methods and devices for inserting an inflatable member into position in the opening of the organ wall or other tissue during an endoscopic surgical procedure.